PACKAGE INFORMATION LEAFLET

Dopamine Hydrochloride 40mg/ml

Concentrate for Solution for InfusionRead all of this leaflet carefully before you start using this medicine.Keep this leaflet. You may need to read it again.If you have any further questions, ask your doctor or nurse.If any of the side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Dopamine Hydrochloride 40mg/ml Concentrate for Solution for Infusion. It will be referred to as “Dopamine Concentrate” for ease of use hereafter.

What is in this leaflet:1. What Dopamine Concentrate is and what it is used for2. What you need to know before you are given Dopamine Concentrate3. How Dopamine Concentrate is given to you4. Possible side effects5. How to store Dopamine Concentrate6. Contents of the pack and other information

1. WHAT DOPAMINE CONCENTRATE IS ANDWHAT IT IS USED FOR

Dopamine Hydrochloride 40mg/ml Concentrate For Solution For Infusion contains 200mg of Dopamine Hydrochloride which helps to increase the strength of muscle contraction in the heart.It is used to correct poor circulation to the tissues• when there is a low output of blood from the heart and shock

associated with damage to the heart muscle due to obstruction of itsblood supply.

• also after an injury, blood infection, heart failure and open heartsurgery.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVENDOPAMINE CONCENTRATE

You should not be given this medicine if:• you are allergic to Dopamine hydrochloride or any other ingredients

of this medicine (listed in section 6).• you have been told by your doctor that you have a tumour of the

adrenal gland (phaeochromocytoma).• you have abnormal heartbeats and uncoordinated contraction of the

heart muscles.• you have an overactive thyroid gland.

Warnings and precautionsTalk to your doctor or nurse before using Dopamine Concentrate if:• you have any heart related problems• you have recently used monoamine oxidase inhibitors (known as

MAOIs which are used for the treatment of depression; see section“Taking other medicines” for further information)

• you are sensitive to sulphite• you have a weaker pulse in your wrists than normal on examination• you have a blood disorder in which the volume of circulating blood is

decreased (hypovolaemia)• you know that you are suffering or have suffered from problems

related to circulation of blood in your hands and feet (peripheralvascular disease)

• you have any kidney or liver diseases• you are pregnant or breast feeding• you have diabetesSpeak to your doctor before you are given this injection if this applies toyou.Your doctor will monitor you for any side-effects affecting the heart orkidneys while you are receiving dopamine.Dopamine infusion should be withdrawn gradually, to avoid low bloodpressure.

Other medicines and Dopamine ConcentrateTell your doctor if you are taking, have recently taken or might take any other medicines.Some medicines can interact with Dopamine Concentrate, which can significantly alter their effects. If you are already taking one of the following medicines, speak to your doctor before you receive thismedicine:• Monoamine oxidase inhibitors (used for the treatment of depression)

or if you have taken them in the last 14 days, e.g. phenelzine,moclobemide, rasagiline, selegiline, entacapone.

• Water tablets (diuretics), e.g. furosemide, amiloride or triamterene.• Medicines which are often used for treating blood pressure and heart

disorders (alpha and beta blockers e.g. propranolol, tolazoline).• Medicines used to treat epilepsy (phenytoin).• Medicines used to treat migraine (e.g. ergotamine derived from ergot

alkaloids, methysergide).• Medicines used to treat depression such as Tricyclic antidepressants

(e.g. amitriptyline).• Medicines used to reduce high blood pressure like guanethidine.• Medicine used to help your breathing (doxapram).• Medicines used to treat psychological problems like schizophrenia

(e.g. haloperidol, clozapine).Tell your doctor before you are given Dopamine Concentrate if you have recently received any anaesthetic agent such as halothane, isoflurane or cyclopropane.

Pregnancy and breast-feeding and fertilityIf you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. As with all drugs, this medicine should only be given in pregnancy and when breast feeding if absolutely necessary. Your doctor will be able to advise you.

Driving and using machinesNot applicable

Dopamine Concentrate contains:Sodium metabisulphite, which may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm (breathing difficulties).This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

3. HOW DOPAMINE CONCENTRATE IS GIVEN TO YOU

This injection will be administered under the supervision of a doctor. The solution is diluted before administration and will then be given by infusion (as a drip through a needle or tube) into a vein.Your doctor will decide on the most suitable dose for you. This product is not recommended for use in children.If you think you have been given more Dopamine Concentrate than you should haveAs the injection will be administered under the supervision of a doctor, it is unlikely that you will be given more than is necessary. However, if you have any concerns about the dose of your medicine discuss them with your doctor.If you develop symptoms like narrowing of the blood vessels, tissue death around blood vessels, restriction in blood supply due to tissue damage due to over use of this product your doctor will stop giving you this medicine and give you other medications for treatment.If you have any further questions on the use of this medicine ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines Dopamine Concentrate can sometimes cause side effects, although not everybody gets them.All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face, lips, rash or itching (especially affectingyour whole body), should be reported to a doctor immediately.

Other side effects:Common (may affect up to 1 in 10 people):• headache• a rapid or slow heart beat, chest pain, irregular heart beat and

awareness of a rapid or irregular pulse• difficulty in breathing• low blood pressure (which may cause symptoms such as faintness

or dizziness)• narrowing of blood vessels (which may cause the skin to become

cold and to turn pale or to have a bluish colour)• nausea and vomiting

Uncommon (may affect up to 1 in 100 people):• dilation of the pupil of the eye which may cause difficulty with bright lights• shortness of breath• goose pimples or hair 'standing at ends'• pain in your fingers or toes (at higher doses, especially in people who

have had problems with their circulation, gangrene can occur)• abnormalities in the ECG (a tracing of electrical currents in the heart)• high blood pressure.• an excess of urea or other waste products in the blood (which may

make you feel generally unwell and is identified by blood tests)If dopamine hydrochloride escapes from the vein into the surrounding tissues during administration, it may cause damage of the surrounding tissues; tell your doctor if you notice any pain or swelling at the injection site so that the appropriate treatment may be given.Reporting of side effectsIf you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. or search for MHRA Yellow Card in the Google Play or Apple App Store.

5. HOW TO STORE DOPAMINE CONCENTRATE

Keep this medicine out of the sight and reach of children.Do not use this medicine after the expiry date printed on the ampoule and carton. The expiry date refers to the last day of that month.Do not store above 25°C.Keep the container in the outer carton in order to protect from light.If only part used, discard the remaining solution.If the solution appears darker than slightly yellow or discoloured in any other way, it should be returned unused to the pharmacist.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

The active substance is dopamine hydrochloride. The other ingredients are sodium metabisulphite (E223) in water for injections.

What Dopamine Concentrate looks like and contents of pack Dopamine Concentrate is a clear, colourless or pale yellow solution presented in 5ml clear glass ampoules (small glass bottles).Each 5ml ampoule contains 200mg Dopamine Hydrochloride.There are ten 5ml ampoules packed in to one cardboard box.

Marketing authorization holderMercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland.

ManufacturerDelpharm Tours, Rue Paul Langevin, Chambray Lès Tours, 37170 France.

This leaflet was last revised in April 2019 .

LF-117822-01

PACKAGE INFORMATION LEAFLET

Dopamine Hydrochloride 40mg/ml

Concentrate for Solution for InfusionRead all of this leaflet carefully before you start using this medicine.Keep this leaflet. You may need to read it again.If you have any further questions, ask your doctor or nurse.If any of the side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Dopamine Hydrochloride 40mg/ml Concentrate for Solution for Infusion. It will be referred to as “Dopamine Concentrate” for ease of use hereafter.

What is in this leaflet:1. What Dopamine Concentrate is and what it is used for2. What you need to know before you are given Dopamine Concentrate3. How Dopamine Concentrate is given to you4. Possible side effects5. How to store Dopamine Concentrate6. Contents of the pack and other information

1. WHAT DOPAMINE CONCENTRATE IS AND WHAT IT IS USED FOR

Dopamine Hydrochloride 40mg/ml Concentrate For Solution For Infusion contains 200mg of Dopamine Hydrochloride which helps to increase the strength of muscle contraction in the heart.It is used to correct poor circulation to the tissues• when there is a low output of blood from the heart and shock

associated with damage to the heart muscle due to obstruction of itsblood supply.

• also after an injury, blood infection, heart failure and open heart surgery.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DOPAMINE CONCENTRATE

You should not be given this medicine if:• you are allergic to Dopamine hydrochloride or any other ingredients

of this medicine (listed in section 6).• you have been told by your doctor that you have a tumour of the

adrenal gland (phaeochromocytoma).• you have abnormal heartbeats and uncoordinated contraction of the

heart muscles.• you have an overactive thyroid gland.

Warnings and precautionsTalk to your doctor or nurse before using Dopamine Concentrate if:• you have any heart related problems• you have recently used monoamine oxidase inhibitors (known as

MAOIs which are used for the treatment of depression; see section“Taking other medicines” for further information)

• you are sensitive to sulphite• you have a weaker pulse in your wrists than normal on examination• you have a blood disorder in which the volume of circulating blood is

decreased (hypovolaemia)• you know that you are suffering or have suffered from problems

related to circulation of blood in your hands and feet (peripheralvascular disease)

• you have any kidney or liver diseases• you are pregnant or breast feeding• you have diabetesSpeak to your doctor before you are given this injection if this applies to you.Your doctor will monitor you for any side-effects affecting the heart or kidneys while you are receiving dopamine.Dopamine infusion should be withdrawn gradually, to avoid low bloodpressure.

Other medicines and Dopamine ConcentrateTell your doctor if you are taking, have recently taken or might take any other medicines.Some medicines can interact with Dopamine Concentrate, which can significantly alter their effects. If you are already taking one of the following medicines, speak to your doctor before you receive thismedicine:• Monoamine oxidase inhibitors (used for the treatment of depression)

or if you have taken them in the last 14 days, e.g. phenelzine,moclobemide, rasagiline, selegiline, entacapone.

• Water tablets (diuretics), e.g. furosemide, amiloride or triamterene. • Medicines which are often used for treating blood pressure and heart

disorders (alpha and beta blockers e.g. propranolol, tolazoline).• Medicines used to treat epilepsy (phenytoin).• Medicines used to treat migraine (e.g. ergotamine derived from ergot

alkaloids, methysergide).• Medicines used to treat depression such as Tricyclic antidepressants

(e.g. amitriptyline).• Medicines used to reduce high blood pressure like guanethidine.• Medicine used to help your breathing (doxapram).• Medicines used to treat psychological problems like schizophrenia

(e.g. haloperidol, clozapine).Tell your doctor before you are given Dopamine Concentrate if you have recently received any anaesthetic agent such as halothane, isoflurane or cyclopropane.

Pregnancy and breast-feeding and fertilityIf you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. As with all drugs, this medicine should only be given in pregnancy and when breast feeding if absolutely necessary. Your doctor will be able to advise you.

Driving and using machinesNot applicable

Dopamine Concentrate contains:Sodium metabisulphite, which may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm (breathing difficulties).This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

3. HOW DOPAMINE CONCENTRATE IS GIVEN TO YOU

This injection will be administered under the supervision of a doctor. The solution is diluted before administration and will then be given by infusion (as a drip through a needle or tube) into a vein.Your doctor will decide on the most suitable dose for you. This product is not recommended for use in children.If you think you have been given more Dopamine Concentrate than you should haveAs the injection will be administered under the supervision of a doctor, it is unlikely that you will be given more than is necessary. However, if you have any concerns about the dose of your medicine discuss them with your doctor.If you develop symptoms like narrowing of the blood vessels, tissue death around blood vessels, restriction in blood supply due to tissue damage due to over use of this product your doctor will stop giving you this medicine and give you other medications for treatment.If you have any further questions on the use of this medicine ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines Dopamine Concentrate can sometimes cause side effects, although not everybody gets them.All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face, lips, rash or itching (especially affectingyour whole body), should be reported to a doctor immediately.

Other side effects:Common (may affect up to 1 in 10 people):• headache• a rapid or slow heart beat, chest pain, irregular heart beat and

awareness of a rapid or irregular pulse• difficulty in breathing• low blood pressure (which may cause symptoms such as faintness

or dizziness)• narrowing of blood vessels (which may cause the skin to become

cold and to turn pale or to have a bluish colour)• nausea and vomiting

Uncommon (may affect up to 1 in 100 people):• dilation of the pupil of the eye which may cause difficulty with bright

lights• shortness of breath• goose pimples or hair 'standing at ends'• pain in your fingers or toes (at higher doses, especially in people who

have had problems with their circulation, gangrene can occur)• abnormalities in the ECG (a tracing of electrical currents in the heart)• high blood pressure.• an excess of urea or other waste products in the blood (which may

make you feel generally unwell and is identified by blood tests)If dopamine hydrochloride escapes from the vein into the surrounding tissues during administration, it may cause damage of the surrounding tissues; tell your doctor if you notice any pain or swelling at the injection site so that the appropriate treatment may be given.Reporting of side effectsIf you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. or search for MHRA Yellow Card in the Google Play or Apple App Store.

5. HOW TO STORE DOPAMINE CONCENTRATE

Keep this medicine out of the sight and reach of children.Do not use this medicine after the expiry date printed on the ampoule and carton. The expiry date refers to the last day of that month.Do not store above 25°C.Keep the container in the outer carton in order to protect from light.If only part used, discard the remaining solution.If the solution appears darker than slightly yellow or discoloured in any other way, it should be returned unused to the pharmacist.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

The active substance is dopamine hydrochloride. The other ingredients are sodium metabisulphite (E223) in water for injections.

What Dopamine Concentrate looks like and contents of pack Dopamine Concentrate is a clear, colourless or pale yellow solution presented in 5ml clear glass ampoules (small glass bottles).Each 5ml ampoule contains 200mg Dopamine Hydrochloride.There are ten 5ml ampoules packed in to one cardboard box.

Marketing authorization holderMercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland.

ManufacturerDelpharm Tours, Rue Paul Langevin, Chambray Lès Tours, 37170 France.

This leaflet was last revised in April 2019 .

LF-117822-01